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Whistle-Blower Alarmed at Stem Cell Work

Whistle-Blower Alarmed at Stem Cell Work
By ELIZABETH WARMERDAM
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OAKLAND, Calif. (CN) - A stem cell research company fired a manager after he complained that deficiencies in the company's cell lines put patients at risk of infection or death during clinical trials, the man claims in court.
Rob Williams sued StemCells Inc. on Monday in Alameda County Court, alleging wrongful termination, retaliation and violation of the California False Claims Act.
To receive millions of dollars in government funding, including grants from the California Institute for Regenerative Medicine, StemCells claims that its manufacturing processes yield stem cells that are "safe for human stem cell transplantation," the complaint states.
StemCells must follow a set of standards - Good Manufacturing Practices - set forth by the FDA to protect the public, according to the complaint.
Williams says he was hired as the company's senior manager of manufacturing in December 2013 to oversee its manufacturing facility, where stem cell cultures are cultivated for use in clinical trials.
"Shortly after beginning his employment, plaintiff noted poor sterile technique, failure to adhere to current Good Manufacturing Practices in the company's manufacturing process, and substantial deficiencies in the company's Manual Aseptic Processing of HuCNS-SC (Human Central Nervous System Stem Cells) cell lines - failure and deficiencies that put patients at risk of infection or death during ongoing clinical trials," Williams says.
Williams claims he also saw manufacturing deviations during cryopreservation of Working Cell Bank lots, leading to numerous stem cell lots with dangerously high numbers of damaged cells.
"Knowing that these cells were to be injected into human patients, and that the high level of damaged cells and the possibility of contaminating microorganisms could cause serious harm to patients, plaintiff immediately took his concerns to upper management. He also noted that the use of adulterated stem cells lots could skew patient test results, effectively jeopardizing data behind years of clinical trials and research," the complaint states.
Williams says he was told to conceal his findings from reports, and the company suspended him shortly thereafter.
Williams sent emails to company leadership and members of the company's executive team reiterating his concerns about the processes used to create the stem cell lines for use in human patients. He also described the suspension he faced as retaliation for bringing the issue out into the open, the complaint states.
StemCells fired Williams a few weeks later, he says.
Williams seeks punitive damages.
He is represented by Daniel Velton with Velton Zegelman, of Sunnyvale.
StemCells said in an email that Williams "was terminated for performance deficiencies, and [the company] finds no merit to the allegations."
It added: "To date, no patients participating in the Company's clinical studies have experienced any product related safety concerns."

"I'm manic as hell-
But I'm goin' strong-
Left my meds on the sink again-
My head will be racing by lunchtime"